Duns Number:116956644
Device Description: Antibacterial Strong Strips Extra Large Adhesive Bandages, all one size, 1 3/4 IN x 4 IN ( Antibacterial Strong Strips Extra Large Adhesive Bandages, all one size, 1 3/4 IN x 4 IN (44 mm x 101 mm)
Catalog Number
-
Brand Name
Health Mart
Version/Model Number
052569134962
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
28820ef9-aaf9-44f1-b6bc-2c3eb5467a2c
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
July 31, 2020
Package DI Number
20052569134966
Quantity per Package
36
Contains DI Package
00052569134962
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |